Phase 3
N=148
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Meniere Disease
Bottom Line
View on ClinicalTrials.gov: NCT03664674 ↗Enrolled (actual)
148
Serious AEs
2.7%
Results posted
Dec 2022
Primary outcome: Primary: 28-Day Average DVD at Week 12 (Month 3) — 2.869; 3.577 DVD — p=0.312
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OTO-104 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otonomy, Inc.
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 28-Day Average DVD at Week 12 (Month 3) |
2.869; 3.577 | 0.312 |
| SECONDARY Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden |
0.998; 1.643 | — |
| SECONDARY Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit |
0; 0 | — |
| SECONDARY Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) |
5; 7 | — |
| SECONDARY Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) |
4; 4 | — |
| SECONDARY Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3) |
2; 9 | — |
Summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Eligibility Criteria
Inclusion Criteria
- Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
- Subject has experienced active vertigo during the lead-in period.
- Subject has documented asymmetric sensorineural hearing loss.
- Subject agrees to maintain their current treatments for Meniere's disease while on-study.
Exclusion Criteria
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
- Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- Subject has a history of vestibular migraine.
- Subject has used an investigational drug or device in the 3 months prior to screening.
- Subject has previously been randomized to a clinical study of OTO-104.
Data sourced from ClinicalTrials.gov (NCT03664674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.